FDA Advisors Set To Discuss Abbott's TriClip For Heart Valve Disorder As Questions On Pivotal Trial Loom

On Tuesday, February 13, 2024, the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet regarding the premarket approval application (PMA) for Abbott Laboratories ABT TriClip G4 System.

The TriClip G4 System is indicated for patients with symptomatic severe tricuspid regurgitation (TR) despite being treated optimally with medical therapy, who are at intermediate or greater risk for surgery, and in whom tricuspid valve edge-to-edge repair (TEER) is appropriate.

TR is a type of heart valve disease that occurs when the valve’s flaps (cusps or leaflets) do not close properly, potentially causing heart failure.

On Friday, the committee released the briefing document.

Even though the TRILUMINATE pivotal trial met its primary endpoint, the agency reviewers seem to have raised some issues.

The reviewers said, “Although the Breakthrough Device Program offers expanded opportunities to utilize efficient and flexible clinical study designs, a Breakthrough Device designation does not modify or reduce the statutory requirement for PMA approval. The totality of the data still needs to demonstrate that the device provides a reasonable assurance of safety and effectiveness for its intended population.”

The document also noted that since the TRILUMINATE pivotal trial was an unblinded. Patient-reported outcomes such as the KCCQ score could be subject to the placebo effect in an unblinded trial. 

The primary endpoint of the TRILUMINATE pivotal trial was met, driven only by KCCQ score improvement in the device. Mortality, or tricuspid valve surgery rates, were similar between treatment groups, and the HF hospitalization rate was numerically higher in the TriClip group vs. the control group.

Earlier this month, the FDA approved Edwards Lifesciences Corporation’s EW transcatheter Evoque tricuspid valve replacement system (Edwards Lifesciences) for severe TR without convening an advisory committee. 

That approval was based on the TRISCEND II study results, which showed the device significantly improved TR grade and led to meaningful improvements in functional status and symptoms in patients with severe TR.

Price Action: ABT shares are down 0.38% at $111.38 on the last check Monday.